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Impurity Isolation and Identification


Impurity Isolation and Identification

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Identification of impurities and degradation products during drug discovery and development are dictated by various guidelines of domestic and international health authorities. Impurity identification is also critical to enable process optimization to improve the yield and quality of the product.

Major Services

  • Isolation of impurities of regulatory starting materials, intermediates, APIs and drug products using various techniques including preparative HPLC and SFC
  • Structure elucidation of isolated impurities by acquisition and interpretation of comprehensive 1D/2D NMR and LC-MS data
  • Isolation and structure elucidation of forced oxidation degradants of APIs
  • Fast purity determination of raw materials, intermediates, APIs and synthetic impurities by quantitative NMR (QNMR)

State-of-the-art facilities

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